Ocugen, Inc.

Good morning and welcome to the Ocugen conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Ken Enchausti, head of investor relations and communications for Ocugen. You may begin.

Thank you, operator. I'd like to welcome you to our conference call. With me today are Ocugen's chairman, CEO, and co-founder, Dr. Shankar Musunuri, who will provide a business update, and our chief financial officer and head of corporate development, Sanjay Subramanian, who will provide a financial update. Earlier this morning, we issued a press release, including a business update and third quarter 2021 financial results. We encourage listeners to review the press release which is available on our website at www.Occugen.com. This call is also being recorded, and a replay along with accompanying slide presentation will be available on the investor section of the Occugen website for approximately 45 days. As always, we need to advise you that this call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual events or actual results to differ materially from expectations, including, among other things, the uncertainties inherent in research and development of our product candidates, risks to our business related to the ongoing COVID-19 pandemic, uncertainty regarding whether the FDA will grant us emergency use authorization for Kavaxin in ages 2 to 18, and when we will be able to submit a biologics license application for Kavaxin to the FDA. and whether and when we will receive regulatory approvals for authorizations for Kavaxin in the US or Canada. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission, including the risk factors described in the section entitled Risk Factors in the quarterly and annual reports that we file with the SEC. You should read carefully the risks and uncertainties described in today's press release and accompanying slide presentation. as well as the risk factors included in our filings with the SEC. Note that we intend to file a Form 10Q with the SEC today. I will now turn the call over to OccuGEN's Chairman and CEO, Dr. Shankar Musanuri.

Thank you, Ken. Good morning, everyone, and thank you for joining. We hope you and your families are safe and well. Today, we're here to review a rapid succession of milestones from this company I feel privileged to lead. It reminds me of the famous Margaret Mead quote, never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it's the only thing that ever has. These words remind me that just one year ago, oxygen was less than 20 individuals. We all had a vision to bring new therapies that could tackle serious diseases and bring new options for people wanting a choice. We have completed three quarters of 2021 and our oxygen family has grown significantly, committed to bringing Covaxin BBV152, our COVID-19 vaccine candidate, to the United States and Canada, along with our lead candidate for blindness diseases, OQ400, which is a part of our modifier gene therapy platform. Today's update is a result of their hard work, along with the efforts of our global partners, Bharat Biotech and ConsinoBio. Thank you all for your contributions. This slide outlines the major events that transpired over the recent months, including the third quarter of 2021. First, we want to congratulate our partners at Barth Biotech for securing an emergency use listing for Covaxin by the World Health Organization. This is exciting news. That's a tremendous accomplishment and a critical validator for broadening the global portfolio of COVID-19 vaccines. and is noticed by the regulatory authorities around the world. Closer to home, Aquigen took significant steps to progress Covaxin PBV152 with the U.S. Food and Drug Administration. Last week, we submitted Covaxin for emergency use authorization at the FDA for use among those aged 2 to 18 years. We believe there is a significant unmet need within this age group knowing that there is a lack of choice for different vaccines within the U.S. market. Particularly in ages 2 to 5, there is currently no approved option. We believe the data, as we top-lined on our Friday call, November 5th press release, make a compelling efficacy and safety case to the agency, and we look forward to furthering our discussions with them. And in late October, we filed an investigational new drug application to support the initiation of a Phase III immuno-bridging study between the U.S. population and the results of Bharat Biotech's Phase III clinical trial involving nearly 25,800 participants. This Phase III bridging trial is being conducted in support of an upcoming BLA. Our trial had designation acute O002 and will involve a few hundred subjects. The primary objective will be to compare neutralizing titers between the US-based participants who get two doses of Covaxin to those who got two doses in the Phase III efficacy trial in India. Secondary objectives include measuring the immunogenicity of two doses of Covaxin over time in those who are of age between 18 and 65 in those over the age of 65, as well as determining its immunobroadening effect, including in those who previously received an mRNA vaccine. Such a broadening effect could include antibody responses against multiple antigens, such as spike and nucleocapsid proteins. We're also preparing for the possibility of conducting a safety bridging trial if required. We are hearing from many people about their interest in participating in this clinical trial, if approved. We are very appreciative of their passion and ask that they stay tuned for further developments. To the north, our engagement with Health Canada continues and responses to deficiencies noted are being prepared. As a reminder, we applied for approval under the interim order and our application was automatically transferred to a new drug submission process. I now want to update you on our progress with our modifier gene therapy program. I'm pleased to announce that yesterday, OQGEN filed an investigational new drug application for OQ400, our lead candidate in the modifier gene therapy platform for the treatment of retinitis pigmentosa resulting from genetic mutations NR2E3 and rhodopsin. This is a proposed safety and dose finding Phase 1-2 clinical trial involving a small number of patients. We have already successfully completed manufacturing at commercial scale, at 200 liter scale, to support clinical studies. As part of the clinical trial, patients will be observed post-dose for at least 12 months. From there, OCU-400 could move into a Phase 3 clinical trial, evaluating its ability to address multiple inherited retinal disease mutations. This is the beginning of a new journey, one started by our partner, Dr. Nina Hader from Harvard Medical School, and we look forward to sharing the progress of our trial, if approved, throughout 2022. Following close behind RQ400 is our next candidate, RQ410. IND-enabling preclinical studies have started to support a future Phase I-II clinical trial. Ocu410 is designed to address dry age-related macular degeneration. It's the most prevalent chronic form of AMD, accounting for approximately 90% of total AMD cases, and is characterized by slow, progressive dysfunction of the retinal pigment epithelium, photoreceptor loss, and retinal degeneration. With about 150 million people suffering from dry AMD around the world and no treatment options available, there is significant unmet medical need. Preclinical data recently presented at the Dry AMD Therapeutics Conference in October suggest that Ocu410 plays a role in the genes associated with how dry AMD develops over time and we will continue to explore this area throughout 2022. We are pleased to share that in order to support the manufacturing of RQ410, we have expanded our arrangement with ConsinoBio to be our partner responsible for chemistry, manufacturing, and controls development and manufacturing. They will now support the CMC development and manufacturing for both the RQ400 and RQ410 programs. Our agreement with ConsinoBio was amended in September to add this program. Rounding out Our ocular portfolio, OCU-200, our transferring thumb statin fusion protein, is still progressing well. We are on track with our preclinical activities to explore further how it can help those with diabetic macular edema, diabetic retinopathy, and wet age-related macular degeneration. With OCU-400 moving into clinic and OCU-410 and OCU-200 continuing their IND-enabling studies, our focus on ocular therapies remains very strong. This indeed has been a busy quarter with much going on to advance Covaxin and our ocular portfolio, and there is much more ahead. I will now turn the call over to Sanjay to provide our third quarter 2021 financial update. Sanjay?